FDA 510(k)

MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

K-Number: K935506 · 1994-02-03

ApplicantKawasumi Laboratories Co., Ltd.

Decision Date1994-02-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K935506. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION?

MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K935506.

When did MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION receive FDA 510(k) clearance?

MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION received FDA 510(k) clearance on 1994-02-03, under 510(k) number K935506.

Who is the listed applicant for MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION?

The FDA 510(k) record lists Kawasumi Laboratories Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION?

The FDA product code for MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION is FMI.

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Other records listing Kawasumi Laboratories Co., Ltd. as applicant

K994323KAWASUMI LABORATORIES PHILEBOTOMY SET K974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE K935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER K935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER K930012KAWASUMI LABORATORIES K-CUFF

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.